Diacerein-containing medicines for oral administration

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CMDh position
  • European Commission final decision
Current status:
European Commission final decision

Overview

 

Restrictions to the use of diacerein-containing medicines

Restrictions intended to limit risks of severe diarrhoea and effects on the liver

On 19 March 2014, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh)1 endorsed recommendations to restrict the use of diacerein-containing medicines in order to manage the risks of severe diarrhoea and effects on the liver.

Due to the risks associated with severe diarrhoea, diacerein is no longer recommended in patients aged 65 years and above. It is also advised that patients start treatment on half the normal dose (i.e. 50 mg daily instead of 100 mg) and should stop taking diacerein if diarrhoea occurs.

In addition, diacerein-containing medicines must now not be used in any patient with liver disease or a history of liver disease, and doctors should be monitoring their patients for early signs of liver problems.

Doctors should also note that, based on available data, the use of diacerein is to be limited to treating symptoms of osteoarthritis affecting the hip or knee. Treatment should only be started by doctors experienced in treating osteoarthritis.

These recommendations are based on the review of the benefits and risks of diacerein conducted by the EMA's Pharmacovigilance and Risk Assessment Committee (PRAC) and follow concerns raised by the French medicines agency (ANSM) about diacerein's gastro-intestinal and liver effects. The CMDh endorsed the PRAC's final recommendations to address these concerns and ensure that diacerein's benefits continue to outweigh its known risks.

As the CMDh position on diacerein was adopted by majority vote, it was sent to the European Commission which endorsed it and issued a final legally binding decision valid throughout the European Union (EU) on 4 September 2014.


1The CMDh is a medicines regulatory body representing the European Union (EU) Member States.

Key facts

About this medicine
Approved name
Diacerein-containing medicines for oral administration
International non-proprietary name (INN) or common name
diacerein
Associated names
Zondar
Class
-
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1349
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Decision making model
PRAC-CMDh
Authorisation model
Nationally authorised product(s)
Key dates and outcomes
Procedure start date
29/11/2012
PRAC recommendation date
06/03/2014
EC decision date
04/09/2014
Outcome
Variation

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Position provided by CMDh

European Commission final decision

  • List item

    Diacerein Article-31 referral - Restrictions to the use of diacerein-containing medicines (PDF/83.41 KB)


    First published: 19/09/2014
    Last updated: 19/09/2014
    EMA/544268/2014

  • List item

    Diacerein Article-31 referral - Annex III (PDF/78.91 KB)


    First published: 19/09/2014
    Last updated: 19/09/2014

  • List item

    Diacerein Article-31 referral - Restrictions to the use of diacerein-containing medicines (PDF/83.41 KB)


    First published: 19/09/2014
    Last updated: 19/09/2014
    EMA/544268/2014

  • List item

    Diacerein Article-31 referral - Annex II (PDF/66.46 KB)


    First published: 19/09/2014
    Last updated: 19/09/2014

  • List item

    Diacerein Article-31 referral - CMDh divergent position (PDF/50.37 KB)


    First published: 19/09/2014
    Last updated: 19/09/2014

  • List item

    Diacerein Article-31 referral - PRAC assessment report (PDF/375.69 KB)


    First published: 19/09/2014
    Last updated: 19/09/2014

  • List item

    Diacerein Article-31 referral - Annex I (PDF/105.42 KB)


    First published: 19/09/2014
    Last updated: 19/09/2014

  • List item

    Diacerein Article-31 referral - Annex IV (PDF/16.7 KB)


    First published: 19/09/2014
    Last updated: 19/09/2014

  • Description of documents published

    Please note that some of the listed documents apply only to certain procedures.

    • Overview - lay-language summary of the stage of the procedure
    • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
    • Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
    • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
    • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
    • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
    • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
    • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
    • Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
    • Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
    • Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
    • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
    • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
    • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
    • Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

    Note that older documents may have different titles.

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